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Community register of veterinary medicinal products


Product information

Invented name: BLUEVAC BTV8   
Auth. number : EU/2/11/122
Active substance : Bluetongue virus inactivated, serotype 8
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AA - Inactivated viral vaccines
Chemical substance: QI02AA08 - bluetongue virus
(See WHO ATCvet Index)
Indication: Sheep: For the active immunisation of sheep to prevent viraemia* from 2.5 months of age and to reduce clinical signs caused by bluetongue virus serotype 8.Onset of immunity: 20 days after the second dose Duration of immunity: 1 year after the second dose.
Cattle: For the active immunisation of cattle to prevent viraemia* from 2.5 months of age caused by bluetongue virus serotype 8. Onset of immunity: 31 days after the second dose.Duration of immunity: 1 year after the second dose.*(Cycling value (Ct) >= 36 by a validated RT-PCR method, indicating no presence of viral genome)
Marketing Authorisation Holder: CZ Veterinaria, S.A.
La Relva s/n, P.O. Box 16, 36400 Porriño , España
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/04/2011 Centralised - Authorisation EMEA/V/C/156 (2011)2785 of 14/04/2011
16/01/2013 Centralised - Annual reassessment EMEA/V/C/156/S/1 (2013)128 of 14/01/2013
21/01/2014 Centralised - Annual reassessment EMEA/V/C/156/S/2 (2014)311 of 16/01/2014
15/01/2015 Centralised - Variation EMEA/V/C/156/II/4
Updated with Decision(2016)1690 of 15/03/2016
19/01/2015 Centralised - Annual reassessment EMEA/V/C/156/S/3 (2015)225 of 15/01/2015
17/03/2016 Centralised - Variation EMEA/V/C/156/R/6 (2016)1690 of 15/03/2016
18/07/2016 Centralised - Variation EMEA/V/C/156/IAIN/8
Updated with Decision(2017) 5614 of 03/08/2017
07/08/2017 Centralised - Yearly update (2017) 5614 of 03/08/2017
16/02/2018 Centralised - Variation EMEA/V/C/156/IB/9